Photodynamic Therapy Associated With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma

January 28, 2026 updated by: Ana Gabriela Salvio, University of Sao Paulo

Optimization of Photodynamic Therapy Through the Association With Sonodynamic Therapy for the Treatment of Nodular Basal Cell Carcinoma

Evaluation of a therapeutic protocol based on the combination of photodynamic therapy and sonodynamic therapy, referred to as sonophotodynamic therapy. Since this new protocol is applied in a single day, it is called the single-visit Sono-PDT protocol. This protocol will be used for the treatment of nodular basal cell carcinoma lesions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In the proposed treatment protocol, all the procedures of traditional PDT protocol will be maintained, with the addition of a dose of low-intensity therapeutic ultrasound immediately after the application of red light. Ultrasound, due to its greater ability to penetrate the skin, can help reach deeper tumor cells and thus improve treatment outcomes.

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • São Paulo
      • Jaú, São Paulo, Brazil, 17210-080
        • Recruiting
        • Hospital Amaral Carvalho
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults of both sexes, aged 18 years and older.
  • Histologically confirmed nodular basal cell carcinoma with lesion diameter ≤1.0 cm.
  • Participants with multiple lesions may be included, provided that each lesion meets all inclusion criteria.

Exclusion Criteria:

  • Nodular basal cell carcinoma lesions >1.0 cm in diameter.
  • Known hypersensitivity or allergy to methyl aminolevulinate (MAL) or any excipients of the study medication.
  • Histological subtypes of infiltrative basal cell carcinoma, including micronodular, infiltrative, sclerodermiform (morpheaform), plano-cicatricial, or terebrant subtypes.
  • Porphyria or other disorders of porphyrin metabolism.
  • Pregnant or breastfeeding women.
  • Women of childbearing potential not using an acceptable method of contraception.
  • Presence of photosensitive diseases, including lupus erythematosus.
  • Any condition that, in the investigator's opinion, would interfere with study participation or safety.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Photodynamic therapy (PDT) protocol
In this arm, lesions will be treated with the conventional PDT protocol for this type of lesion.
Combination product: Control Arm (Conventional Therapy)
PDT protocol: This intervention consists of two therapeutic sessions performed on the same day. The first session involves the application of MAL (methyl aminolevulinate) cream to the skin tumor, followed by an incubation period of 3 hours. After this time, the lesion is illuminated for 20 minutes at an irradiance of 125 mW/cm² using the LINCE device. Following the illumination procedure, the second session begins with a new application of MAL cream and an additional 1.5 hours of incubation. After this period, illumination is performed using the same light parameters as in the first session. After each MAL application, an occlusive dressing composed of PVC film, aluminum foil, gauze, and adhesive tape is applied to the lesion area to prevent light exposure and degradation of the produced PpIX.
Experimental: Sono-Photodynamic Therapy (SonoPDT) protocol
In this arm, lesions will be treated with a modified treatment protocol called SonoPDT protocol.
Combination product: Experimental arm
SonoPDT protocol: This intervention consists of two therapeutic sessions performed on the same day. The first session involves the application of MAL (methyl aminolevulinate) cream to the skin tumor, followed by an incubation period of 3 hours. After this time, the lesion is illuminated for 20 minutes at an irradiance of 125 mW/cm² using the LINCE device. Immediately after illumination, the lesion will be irradiated with ultrasound (frequency: 1MHz, mode: pulsed, ultrasound intensity: 1.5 W/cm2, duty cycle: 50%, pulse frequency: 100 Hz) for 5 minutes. Following the sonication procedure, the second session begins with a new application of MAL cream with an incubation period of 1.5 hours. After this time, illumination and sonication are performed using the same excitation source parameters as in the first session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the complete response rate after one month of treatment.
Time Frame: One month after the treatment was applied to the patient.
Complete response will be defined as the absence of clinical and/or histopathological signs of the tumor after one month of treatment.
One month after the treatment was applied to the patient.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the complete response rate and recurrence-free survival rate after six months of treatment.
Time Frame: Six months after the treatment was applied to the patient.
Complete response will be defined as the absence of clinical and/or histopathological evidence of the tumor. Recurrence-free survival at 6 months will be determined by the proportion of patients who show no recurrence of the lesion at the treated site or in adjacent areas within 6 months, relative to the total number of patients treated.
Six months after the treatment was applied to the patient.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 24, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 7.810.244
  • U1111-1330-4954 (Other Identifier: UTN (Universal Trial Number))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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